Kornimate/medical-research-clean huggingface dataset:
resident posture biofeedback study

Conditions: Postural; Strain; Healthy

Summary: while a majority of surgical ergonomic studies have been evaluating attending surgeons, few have evaluated surgical ergonomics within the surgical resident. biofeedback devices can be partnered with education and geared towards surgical residents to decrease current and future musculoskeletal disorders, which may in turn lead to longer and more fulfilling careers.

this study aims to use a commercially-available posture training device for surgical residents that sends biofeedback in the form of a gentle vibration if posture has deviated from the upright (neutral) position for a long period of time. for residents performing minimally-invasive procedures with a laparoscopic approach, our overarching hypothesis is that the time spent in a non-upright position will be less after using the posture biofeedback device compared with before. the study hypothesizes that residents will report fewer complaints related to musculoskeletal pain after wearing the posture training device. residents completing general surgery rotations will be recruited and wear a biofeedback device for about four weeks while performing laparoscopic procedures. posture data from the device and survey data in the form of the cornell musculoskeletal discomfort questionnaire (cmdq) will be collected and analyzed.

Eligibility criteria:
inclusion criteria: * surgical residents with surgical experience of at least one year (postgraduate year 2-5) * completing a one-month rotation at the study sites within the general surgery department during the study period exclusion criteria: * clinically diagnosed inflammatory musculoskeletal disorders per self-report * history of orthopedic surgery in the last six months per self-report

Keywords: biofeedback surgery surgical resident
efficacy of propafenone versus dronedarone for the maintenance of sinus rhythm in patients with atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to compare the ability of propafenone and dronedarone to maintain sinus rhythm after dc cardioversion

atrial fibrillation is the most common arrhythmia requiring continuous therapy. conversion to and maintenance of sinus rhythm is important. propafenone and dronedarone has been used as treatment for maintenance of sinus rhythm after dc cardioversion. but there are no direct comparison study. the purpose of this study is to compare the ability of propafenone and dronedarone to maintain sinus rhythm after dc cardioversion.

Eligibility criteria:
inclusion criteria: * a patient with persistent atrial fibrillation who received successful dc cardioversion exclusion criteria: * prior amiodarone use * nyha class iii or iv heart failure * left ventricular ejection fraction \< 35% * second or third av block * sick sinus syndrome * heart rate \< 50 beat per minute * myocardiac infarction within 3 months * pregnant women * severe hepatic dysfunction * qt prolongation \> 500ms or pr interval \> 180ms * history of hypersensitivity for drug

Keywords: atrial fibrillation propafenone dronedarone
foodrx for obesity treatment

Conditions: Obesity; Food Insecurity

Summary: this study is a 3-group, parallel design, randomized controlled trial (rct) in 105 adults with obesity and food insecurity that will compare bwl-alone (including standard-of-care referral and connection with community food resources; n=35) to bwl plus food supplementation with either food vouchers (bwl+voucher; n=35) or home-delivered, medically tailored groceries consistent with bwl recommendations (bwl+home; n=35). all groups will have bwl treatment provided for 24 weeks per clinical guidelines. food vouchers and home will be provided for 24 weeks of treatment. assessments will be conducted at baseline, and weeks 12 and 24.


Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent form 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. age \>18 years 4. bmi \>30 kg/m2 at screening visit 5. screening positive for food insecurity using a score of \>3 on the 10-item us adult food security survey module109 6. completion of baseline assessments 7. ability to engage in physical activity (i.e., can walk at least 2 blocks) 8. willing and able to provide pictures of food receipts to study team (or mail actual receipts) 9. ability to reliably receive packages at a consistent location in a timely manner 10. telephone or internet service to communicate with study staff 11. for females of reproductive potential: agreement to use of highly effective contraception for during study participation exclusion criteria: 1. serious medical conditions (e.g., type 1 or type 2 diabetes, renal failure) that may pose a risk to the participant during intervention, cause a change in weight, or limit ability to adhere to the program's behavioral recommendations 2. significant psychiatric conditions (e.g., active substance abuse, schizophrenia) that may pose a risk to the participant during intervention, cause a change in weight, or limit ability to adhere to the program's behavioral recommendations 3. breastfeeding, pregnant or planning pregnancy in the next 6 months 4. planned move from the philadelphia area in the next 6 months 5. weight loss of \>5 kg in the previous 90 days 6. recently began a course of or changed the dosage of medication that can cause significant weight change (±5 kg) 7. previous or planned obesity treatment with surgery (excluding lap band if removed for \>1 year) or a weight-loss device 8. use of prescription or over the counter medications for chronic weight management in the past 3 months 9. household member already participating in study due to potential contamination effects 10. lack of stable residence and ability to store and prepare food

Keywords: obesity food insecurity weight loss
real-world effectiveness and safety study of sacituzumab govitecan in chinese metastatic breast cancer

Conditions: Breast Cancer

Summary: the aim of this trial is to explore the real-world effectiveness and poteintial predictors of sacituzumab govitecan in chinese metastatic breast cancer patients.


Eligibility criteria:
inclusion criteria: 1. patients aged over 18 years old. 2. metastatic breast cancer included unresectable locally advanced breast cancer, de novo stage iv breast cancer, and recurrent metastatic breast cancer. 3. plan to receive or has received sacituzumab govitecan monotherapy 4. available medical history. exclusion criteria: 1. incomplete medical history. 2. pregnancy or breast-breeding

Keywords: sacituzumab govitecan breast cancer
body weight, aspirin dose and pro-resolving mediators

Conditions: Body Weight

Summary: this study employs a placebo-controlled randomized cross-over design to investigate the impact of body weight and aspirin dose on levels of specialized pro-resolving lipid mediators in blood and neutrophils.


Eligibility criteria:
inclusion criteria: 1. age between 40 and 70 years exclusion criteria: 1. anti-platelet medication use in the past 7 days 2. aspirin intolerance or allergy 3. known bleeding or clotting disorder 4. chronic inflammatory or connective tissue disease 5. immunological deficiency 6. diabetes mellitus 7. prior gastric or bariatric surgery 8. active smoking 9. platelet count \<100,000 10. use of omega-3 fatty acid supplementation 11. use of drugs or supplements known to inhibit cox-1/cox-2/lipoxygenases 12. corticosteroid use 13. recent initiation or change in dose of statin therapy 14. pregnancy

Keywords: aspirin
benefit of scarf support on skin-to-skin time and portage in neonatology and at home

Conditions: Infant, Newborn, Disease

Summary: carrying (or kangaroo carrying) is known to reduce neonatal and child morbidity and mortality and improves the quality of survival of premature and term children during the most fragile growth period, the first thousand days of life. carrying is also a growing brain protection technique and becomes a routine of care in all neonatal units around the world. in university hospital of saint-etienne, the developmental care program has been developed since 2002 in all neonatology units and advocates the practice of skin-to-skin carrying between the parent (father or mother) and his baby, from the time of the hospitalization. professionals in units who have long been thinking about the concept of attachment and the benefits of skin-to-skin, wish to validate the use of the wearing scarf as a tool for the practice of skin -in-skin in neonatology then back home by performing a randomized monocentric prospective longitudinal study.

this study it's a single-center, prospective, randomized study to evaluate the benefit of the scarf in the practice of skin-to-skin and portage (papse group) compared to a skin-to-skin and carry without scarf (pap group).

Eligibility criteria:
inclusion criteria: for the child: * any newborn regardless of gestational age and postnatal age hospitalized in the neonatology department of the university hospital of saint-etienne for the parent (father or mother): * be a parent of a child eligible for the research protocol exclusion criteria: for the child: * need for sedation or analgesia for the duration of the study * orthopedic pathology incompatible with the practice of carrying * other medical contraindications to carriage * absence of parents for the parent (father or mother): * family, social or psychological situation compromising the evaluation * no fluency in the french language

Keywords: newborn parents carrying skin-to-skin scarf
cladribine in combination with gap in patients with refractory/relapsed acute lymphoblastic leukemia

Conditions: Acute Lymphoblastic Leukemia

Summary: the vast majority of patients with all will die of the disease, and no standard chemotherapy regimen were defined for patients with relapsed/refractory all.our previous experience has shown that cladribine in combination of gap (g-csf priming, low dose cytarabine, and pegaspargase) are effective with tolerable toxicity profiling.thus, this phase 2 clincial trial is going to evaluate the efficacy and safety of cladribine in combination with g-csf, low-dose cytarabine and pegaspargase (c-gap) in patients with refractory/relapsed acute lymphoblastic leukemia

all is common in the elderly patients, who can not tolerate the intensified treatments. the vast majority of patients with all will die of the disease, and no standard chemotherapy regimen were defined for patients with relapsed/refractory all. our previous experience has shown that cladribine in combination of gap(g-csf priming, low dose cytarabine, and pegaspargase) are effective with tolerable toxicity profiling.thus, this phase 2 clincial trial is going to evaluate the efficacy and safety of cladribine in combination with g-csf, low-dose cytarabine and aclarubicin (c-cag) in patients with refractory/relapsed acute myeloid leukemia.

Eligibility criteria:
inclusion criteria: * men and women; * clinical diagnosis of relapsed/refractory all; * ecog performance status (ps) score 0-3; * ast and alt \<=2.5 times the institutional uln; * total bilirubin \<=2.0 times the institutional uln * serum creatinine\<2.0 times the institutional uln; * subjects should take effective contraceptive measures，and serum or urine pregnancy tests must be negative during the screening and study periods in women subjects; * patients should understand the disease and voluntarily receive the study regimen and follow-up. exclusion criteria: * concurrent diagnosis of tumors other than all, with exclusion of superficial bladder cancer, basal cell and squamous cell carcinoma, cervical intraepithelial neoplasms (cin), prostatic intraepithelial neoplasms(pin); * active viral or bacterial infection that would impair the ability of the subject to receive protocol therapy; * concurrent autoimmune hemolytic anemia or immune thrombocytopenia; * subjects suffered from aids，active hepatitis b or c virus infection; * dementia or altered mental status that would prohibit the understanding or rendering of informed consent; * be allergic to any component of c-gap regimen; * subjects ever exposed to cladribine or cag-based regimen.
small-volume tubes to reduce anemia and transfusion

Conditions: Blood Loss Anemia

Summary: stratus will evaluate the use of small-volume ("soft-draw") blood collection tubes for laboratory testing in reducing anemia and transfusion in intensive care unit patients without significant adverse consequences. this is a simple, cost-neutral intervention that could improve the quality of patient care and reduce the harms of frequent laboratory testing.

blood sampling can cause significant unnecessary blood loss particularly in the intensive care unit (icu). blood loss contributes to anemia which is highly prevalent in the icu and is associated with major adverse cardiovascular outcomes and death. red blood cell (rbc) transfusions to correct anemia also have significant health risks. using a stepped wedge cluster randomized trial design, the specific aim of the stratus study is to evaluate whether the routine use of small-volume blood collection tubes reduces rbc transfusion compared to standard-volume blood collection tubes in adult icu patients.

Eligibility criteria:
icus will be eligible if they meet the following criteria: 1. adult icu 2. at least 14 level 2-3 icu beds with capacity for invasive mechanical ventilation 3. use of vacuum tubes for routine blood collection 4. able to achieve at least 25% estimated reduction in blood volume by switching to small-volume vacuum tubes 5. electronic administrative and health record data available for data collection

Keywords: anemia blood transfusion intensive care unit blood sampling stepped wedge red blood cells
support-d intervention for persons with alzheimer's disease and their caregivers

Conditions: Alzheimer Disease; Mild Cognitive Impairment

Summary: the purpose of this research is pilot test a nurse led intervention previously used in patients with pulmonary fibrosis and their caregivers in a new population (persons living with mild cognitive impairment or alzheimer's disease and their caregivers. the researchers hypothesize improving advanced care planning in this population will result in enhanced quality of life over illness trajectory and improve safety for community dwelling pwd/cg dyads. findings from this study will inform additional necessary adaptations required prior to conducting larger scale powered randomized control trial.


Eligibility criteria:
inclusion criteria: the participants in this study include persons with alzheimer's disease (pwd) and their caregivers (cg. * persons with alzheimer's disease (investigators anticipate cognitive impairment within this group) * 18 years old or older * diagnosis of alzheimer's disease or suspected alzheimer's disease (fast score \< 4) * able to read and speak english (intervention in english) caregivers (cg) * \> 18 years old * non-paid (eliminates professional caregivers) * provides care to someone living with alzheimer's disease or suspected alzheimer's disease (self-report) * able to read and speak english (written materials in english) * no diagnosis of cognitive impairment exclusion criteria: * inability or unwillingness to provide informed consent
irritation and sensitization study of hp-5000 topical system

Conditions: Osteoarthritis of the Knee

Summary: this study will assess skin irritation and sensitization for hp-5000 patch in healthy subjects.

this is an evaluator-blinded, randomized phase 1 study evaluating skin irritation and sensitization of hp-5000 topical system in comparison to control patches. the study will consist of a 4-week screening phase and a treatment phase. the treatment phase will consist of the following periods: an induction period, a rest period followed by a challenge period and if needed, a re-challenge period.

Eligibility criteria:
inclusion criteria: * subject provides written informed consent prior to entering the study or undergoing any study procedures; * subject is a generally healthy male or female 18 to 65 years of age; * subject is considered to be healthy on the basis of medical history, physical examination, vital signs, normal electrocardiogram (ecg) and clinical laboratory test results. exclusion criteria: * subject is pregnant or lactating, or females planning a pregnancy during the course of the trial; * subject has severe cardiac, renal or hepatic impairment; * subject has used any topical drugs at the patch application site within 72 hours prior to dosing.
minerva: minimize right ventricular pacing to prevent atrial fibrillation and heart failure

Conditions: Atrial Fibrillation; Heart Failure, Congestive

Summary: the aim of this study is to test the impact of the managed ventricular pacing (mvp) mode and atrial preventive and antitachycardia pacing therapies on the reduction of a composite clinical outcome composed of any death, permanent atrial fibrillation, and cardiovascular hospitalizations.

kristensen et al. reported that aair pacing reduces atrial fibrillation (af) development compared to dddr pacing in sinus node disfunction patients. several authors have shown that, in patients with intact av conduction, unnecessary chronic rv pacing can cause detrimental effects such as af, left ventricular (lv) dysfunction and congestive heart failure. these findings arose the hypothesis that the non-physiologic nature of ventricular pacing may result in electrophysiological and lv remodeling changes that have potentially deleterious long-term effects. the mvp mode, present in the medtronic pacemaker enrhythm, provides atrial based pacing with ventricular backup. it operates in true aai(r) mode, it provides ventricular backup in case of a single conduction loss and converts to ddd(r) mode in case of persistent loss of av conduction. aim of this study is to test the impact of the mvp pacing mode and atrial preventive and antitachycardia pacing therapies on the reduction of a composite clinical outcome composed by any death, permanent af, cardiovascular hospitalizations.

Eligibility criteria:
inclusion criteria: * class i/class ii indications for dual chamber pacing * previous implant of an enrhythm dual chamber implantable pulse generator (ipg) since maximum 2 weeks * history of atrial arrhythmias (at least one electrocardiogram \[ecg\] or holter documented episodes in the last 12 months) exclusion criteria: * less than 18 years of age * pregnancy * unwilling or unable to give informed consent or to commit to follow-up schedule * medical conditions that preclude protocol required testing or limit study participation * enrolled or intend to participate in another clinical trial during the course of this study * a life expectancy of less than 2 years * patient is a candidate for an implantable cardioverter defibrillator (icd) or cardiac resynchronization therapy (crt) device implant * anticipated major cardiac surgery within the course of this study * permanent iii degree av-block or history of av node ablation * history of permanent af (as defined below) * af ablation (left pulmonary veins) or other cardiac surgery \< 3 months * prior implant of defibrillator device or pacemaker (apart from enrhythm ipg implanted within two weeks) * uncontrolled hyperthyroidism

Keywords: physiological pacing antitachycardia pacing therapies
an observational study of roactemra/actemra (tocilizumab) in rheumatoid arthritis patients

Conditions: Rheumatoid Arthritis

Summary: this multi-center, observational study will evaluate the use in clinical practice and efficacy of roactemra/actemra (tocilizumab) in patients with rheumatoid arthritis. eligible patients initiated on roactemra/actemra treatment according to the approved label will be followed for 6 months.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * moderate to severe rheumatoid arthritis , according to the revised acr criteria * patients initiated on roactemra/actemra treatment (in accordance with the local label) on their treating physicians decision exclusion criteria: * roactemra/actemra treatment more than 8 weeks prior to enrolment visit * previous roactemra/actemra treatment in a clinical trial or for compassionate use * treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before starting treatment with roactemra/actemra * history of autoimmune disease or of any joint inflammatory disease other than ra
antidepressant plus asenapine versus antidepressant plus placebo for depression

Conditions: Major Depressive Disorder Without Psychotic Features

Summary: this is a 6-week comparison of asenapine versus placebo as an add-on to ongoing antidepressant treatment in patients with major depression who have not had a complete therapeutic response to treatment with the antidepressant alone. the investigators hypothesize that added asenapine will produce greater reductions in depression than will added placebo.

the investigators will undertake a 6-week, double-blind, randomized, parallel-group, placebo-controlled trial of adjunctive asenapine in 130 patients with mdd without psychosis who have had an incomplete therapeutic response to treatment with an antidepressant medication alone.

Eligibility criteria:
inclusion criteria: -130 male or female patients, 18-65 years of age, with: 1. dsm-iv diagnosis of mdd without psychosis (single episode or recurrent) confirmed by the mini-international neuro-psychiatric interview (mini) 2. madrs total score \> 20, and item 1 (apparent sadness) score \> 2 at enrollment and randomization 3. inadequate therapeutic response during their current depressive episode; an inadequate therapeutic response will be defined as continued depressive psychopathology (see criterion 2) following \> six weeks of therapy at adequate doses (according to the us label) of any non-tricyclic, non-maoi antidepressant medication exclusion criteria: 1. additional dsm-iv axis i diagnoses other than generalized anxiety disorder, panic disorder with or without agoraphobia, or social phobia within 6 months prior to enrollment 2. dsm-iv axis ii diagnoses that significantly impact the current psychiatric status 3. current mdd episode lasting \> 12 months 4. electroconvulsive therapy within the preceding 6 months 5. substance or alcohol dependence, as defined by dsm-iv criteria, within 6 months prior to enrollment 6. unstable medical illness, epilepsy, traumatic brain injury, parkinson disease, or dementia (mmse \<24) 7. risk of suicide as defined by madrs item 10 score \> 4 8. prior failure to respond to asenapine 9. pregnancy or failure to use an acceptable form of birth control. pregnancy as determined by serum pregnancy test at baseline 10. hepatic impairment and history of low wbc, by medical history and interview.

Keywords: depression antidepressant antipsychotic